PEDIATRIC IV WATCH— 510(k) K852030

Substantially Equivalent

Alltek, Inc.

FDA 510(k) clearance K852030 for PEDIATRIC IV WATCH, Substantially Equivalent on 1985-05-30. Applicant: Alltek, Inc..

Clearance details

Applicant: Alltek, Inc.
Product code: Code FPB
Advisory panel: General Hospital
Date received: 1985-05-08
Decision date: 1985-05-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Nevada City, CA, US

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Adverse events under product code FPB

product code FPB

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.